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Pharmaceutics II FINAL > Tablets Part 2 > Flashcards

Tablets Part 2 Flashcards

1
Q

what is another name for molded tablets

A

tablet triturates

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2
Q

how are tablet triturates prepared? what is another name for them?

A

another name = molded tablets

prepared by molding rather than compression – minimum compression force

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3
Q

molded tablets are usually ___ that contain ____

A

small, cylindrical tablets that usually contain potent drugs

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4
Q

molded tablets/tablet triturates are designed to be….

A

readily and completely soluble in water

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5
Q

what kind of excipients are AVOIDED in the preparation of molded tablets/tablet triturates?

A

any water insoluble excipient

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6
Q

________ tablets are designed to disintegrate and release their medication with no special rate controlling features such as special coatings and other techniques

A

immediate release

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7
Q

rapdily disintegration or dissolving tablets disintegrate or dissolve in the mouth when?

A

within 1 minute, and some are within 10 seconds

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8
Q

what are the excipients used in rapidly disintegrating or dissolving tablets and why?

A

very water soluble excipients because they wick (absorb) water into the tablet for rapid disintegration or dissolution

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9
Q

name 2 techniques used to prepare rapidly disintegrating or dissolving tablets

A

lypophilization or soft direct compression

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10
Q

name 2 products that use the lyophilization method of preparing rapidly disintegrating or dissolving tablets

A

zydis and claritin

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11
Q

name 2 tablets that use the soft direct compression method of preparing rapidly disintegrating or dissolving tablets

A

Dimetapp ND
Tempra Quicklets

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12
Q

which technique of preparing rapdily disintegrating or dissolving tablets is “freeze drying” to increase porosity and allow for it to quickly dissolve

A

lyophilization

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13
Q

true or false

the saliva from rapidly disintegrating or dissolving tablets can be swallowed

A

TRUE – it can. the dose is designed to go through the stomach

however, buccal and sublingual saliva should NOT be swallowed

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14
Q

true or false

compressed tablets must be elegant in appearance

A

TRUE

if not, we have to apply sugar or film coating

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15
Q

compressed tablets must be bioavailable.
this involves the tablet doing what?

A

undergoing disintegration and dissolution

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16
Q

compressed tablets must have uniformity in what 3 things?

A

weight
thickness
drug contents

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17
Q

true or false

it is not necessary for compressed tablets to be sufficiently strong to withstand pressures

A

false - it is

due to manufacturing, packaging, and shipping etc

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18
Q

compressed tablets must retain all functional attributes throughout…..

this involves the drug’s ___ and ___

A

its shelf life

stability and efficacy

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19
Q

the diameter and shape of compressed tablets depends on what?

A

the die and the punches used in compression

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20
Q

the MORE CONCAVE the punches, the ____ convex the compressed tablet

A

more convex

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21
Q

name 6 quality standards and compendial requirements for tablets

which of these are required for capsuels?

A

tablet weight and USP weight variation test
content uniformity
tablet thickness
tablet hardness and friability
tablet disintegration
tablet dissolution

only USP weight variation test and content uniformity is required for capsules

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22
Q

true or false

the USP weight variation test is related to the amount of API contained in the tablet

A

FALSE – related to the total weight of the tablet

the content uniformity test is related to the amount of API

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23
Q

explain how to perform tablet weight variation

A

if tablets are coated, weight 20 tablets individually (if uncoated, weight 10 tablets individuallt)

determine the average weight of the tablets

each INDIVIDUAL tablet should be within 10% of labeled claim. if greater than 10%, must be rejected

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24
Q

tablet weight variation:

for the determination of dosage form uniformity by weight variation, select not _______ tablets

A

not less than 30 tablets

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25
Q

true or false

in tablet weight variation, 10 tablets should be weighted individually if they are coated

A

false – 10 if uncoated
20 if coated

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26
Q

in the content uniformity test, how many tablets are sampled and how many are assayed?

A

30 tablets are sampled and 10 are assayed

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27
Q

in the 10 tablets assayed in the content uniformity test, explain the requirements in order to be accepted

A

the average content of each tablet should be within 85%-115% of the average potency (plus minus 15%)

NONE should be outside of 75%-125%

if any show potency OUTSIDE OF 85%-115%, assay 20 more tablets
to pass this:

-net content of all tablets within 75%-125%
-and the net content of only 1 tablet can be outside 85-115%

if there are more than 2 outside of the 15% range, reject whole batch

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28
Q

explain the tablet thickness test and requirements

A

the thickness and diameter of 20 tablets is measured

for thickness, variation can’t be more than 10%

for diameter, variation can’t be more than 2%

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29
Q

true or false

the tablet thickness test measures both thickness and diameter

A

true

30
Q

in the tablet thickness requirements, the diameter must be within 10% and the thickness must be within 2%.
20 tablets are measured

TRUE OR FALSE

A

false

20 tablets are measures
average variability:
diameter must be within 2%
thickness must be within 10%

31
Q

in measuring tablet hardness, what is the normal minimum quantity of force to be applied?
what is this test called?

A

about 4kg force applied and tablet does not break

stress test

32
Q

name the 2 tests for tablet hardness

A

stress test - force of 4kg is applied and tablet should not break

friability (easily crumbled or broken) test - measures the tablet’s durability. weight loss must be less than 1%. 20 rotations per minute (rpm) is applied

33
Q

true or false

the stress test in which 4kg is applied dto the tablet’s is a measure of the tablet’s friability

A

FALSE - measure of the tablet’s hardness

friability test is when it undergoes 20rpm and less than 1% of the weight can be lost to be accepted

34
Q

why must a tablet be able to disintegrate?

A

for the medicinal agent in the tablet to be fully available for absorption, it must fully disintegrate and release the drug to the body fluids to then undergo DISSOLUTION

if the site of action is the GI tract, the tablet must disintegrate in order to increase the surface area for activity within the GI tract

35
Q

the tablet disintegration test determines what?

A

the disintegration time of 12 tablets
6 used for every test – so 2 tests are done for a total of 12 tabs

36
Q

in the tablet disintegration test, state the amount of time allowed for the full disintegration of these tablets:

uncoated
coated
buccal
sublingal
enteric coated

A

uncoated: no more than 15-30 minutes (30 minutes = compressed tabs)

coated - up to 2 hours

buccal - all tablets within 4 hours

sublingual - 30 seconds - 3 minutes MAX (1 min is goal)

enteric coated - stimulates gastric fluid (WATER NOT USED) for 1 hour – NO cracking or disintegration or anything can be observed after this 1 hour

37
Q

time used for disintegration test for buccal tablets

A

all tablets must disintegrate within 4 hours

38
Q

time required for disintegration test for most uncoated tablets.
what is time for compressed tablets?

A

most uncoated tablets = 15-30 minutes

for compressed - more like 30 mins

39
Q

time required for disintegration test for coated tablets

A

up to 2 hours

40
Q

what is the mesh used in the tablet disintegration test?
how many cycles per minute?
which fluid is used?

A

10 mesh
30 cycles/min
water is used for all tablets EXCEPT enteric coated

for enteric coated, a fluid with a pH of 1 is used to represent the stomach. NO disintegration of cracking or softening can be seen after the 1 hours (bc the whole point of enteric coating is for it not to be absorbed in the stomach, but in the small intestine)

41
Q

what is the rate limiting step for WATER SOLUBLE tablets to provide therapeutic effect?

A

tablet disintegration

dissolution is not a problem for a water soluble drug

42
Q

an indicator of the bioavailability of the drug from the solid dosage form is……

A

tablet dissolution

43
Q

what is tablet dissolution?

A

an indicator of the bioavailability of the drug from the solid dosage form

44
Q

true or false

for a water insoluble drug, disintegration is the rate determining step

A

FALSE - DISSOLUTION

45
Q

what is the criteria for a drug to be water soluble

A

solubility is greater than 10mg/mL at room temp

46
Q

what is the criteria for a drug to be water insoluble

A

solubility is less than 1mg/mL

47
Q

water soluble drug: solubility greater than 10mg/mL

water insoluble drug: solubility less than 1mg/mL

what about drugs whos solubility is between 1mg/mL - 10mg/mL?? what is the rate limiting step?

A

both disintegration AND dissolution are important for these drugs

48
Q

is there an issue?

solubility of drug: 20mg/mL

dose: 50mg

A

yes
there is a solubility issue.

49
Q

what does IVIVC stand for

what is it related to?

A

in vivo in vitro correlation

related to tablet dissolution tests

50
Q

what is the approximate amount of fluids that should be taken with a drug

A

250mL

51
Q

name 3 methods of the manufacture of compressed tablets

A

wet granulation method
dry granulation method
direct compression tableting

52
Q

name 3 common steps for the manufacture of compressed tablets

A

grinding the drug or powder

blending the powders

adding the lubricant

53
Q

what is granulation?

A

process in which a powder mixture is converted to free flowing particles

54
Q

name 3 benefits of performing granulation

A

you can get:

-desired size/distribution
-desired granule shape
-desired granule hardness and density

55
Q

what is one of the most demanding processes in tablet preparation?

A

granulation

56
Q

what is another word for dry granulation?

A

slugging

57
Q

which method of manufacturing compressed tablets is generally used first?

A

wet granulation

58
Q

true or false

there is NO granulation involved in the direct compression method of manufacturing compressed tablets

A

true

59
Q

in dry granulation, a tablet mixture is prepared without….

A

a wet binder or moisture
(liquid)

60
Q

in which method of preparing compressed tablets is a slug formed and then compressed?

A

in dry granulation/slugging

61
Q

why is DIRECT COMPRESSION becoming a more desired method of manufacturing compressed tablets?

A

because of the availability of the excipients needed in this method

62
Q

what is the most widely used and most general method of tablet preparation?

A

wet granulation

63
Q

what is the most expensive method of preparing compressed tablets?

A

wet granulation

64
Q

name 2 advantages of the wet granulation method

A

most reliable method
has the highest probability of meeting the requirements to make a successful tablet

65
Q

name 4 disadvantages of wet granulation

A

-labor intensive
-time consuming
-CANNOT be used for water sensitive drugs
-a uniform granulation needs to be prepared

66
Q

for wet granulation, the drug cannot be….

A

MOISTURE SENSITIVE

67
Q

“the granulation will meet all the physical requirements for the compression of good tablets”

A

wet granulation

68
Q

in wet granulation, how many times is the preparation screened?
explain

A

screened twice

1st time - after damp mass is prepared. no 6 or 8 mesh screen

after drying – screened again
12-20 mesh size (SMALLER)

69
Q

Name 4 uses of lubricant in tablet preparation

A

improves flow from the hopper to the die

prevents adhesion to punches and dies during compression

gives sheen to the finished tablet

reduces friction between tablet and die wall during ejection

70
Q

in wet granulation, how is the granulation dried?

A

by thermostatically controlled ovens that constantly record the time temp and humidty

71
Q
A

Pharmaceutics II FINAL (11 decks)

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